The primary immunogenicity endpoint is the proportion of subjects achieving a post-vaccination serum antibody response for each antigen component of OPV and CAIV-T.

Secondary Outcome Measures:

The secondary endpoint for immunogenicity is the geometric mean titer (GMT) of serum antibody for each antigen component of OPV or the geometric mean ratio relative to the baseline titer of CAIV-T serum antibody components.

Estimated Enrollment:

2400

Study Start Date:

September 2001

Estimated Study Completion Date:

December 2001

Eligibility

Ages Eligible for Study:

6 Months to 36 Months

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

who are aged at least 6 months and less than 36 months of age at the time of first vaccination

who have received a full primary vaccination schedule consisting of three doses of OPV in the first year of life

who are in good health as determined by medical history, physical examination and clinical judgement

whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained

who, along with their parent(s)/legal guardian(s), will be available for duration of the trial (3 months)

whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts [telephone, clinic or home visit].

Exclusion Criteria:

whose parent(s)/legal guardian(s) are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period

with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease

with Down's syndrome or other known cytogenetic disorders

with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids (see Section 4.2.1)

who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study

for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study

have an immunosuppressed or an immunocompromised individual living in the same household

who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational)

with a documented history of hypersensitivity to egg or egg protein or any other component of the assigned study vaccine

who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to vaccination or for which use is anticipated during the study

with any medical conditions that in the opinion of the Investigator might interfere with interpretation of the study results.

If any of these criteria are met following enrollment, the subject will be excluded from subsequent vaccine dosing.

Note: Pregnancy in a household member or any person who has regular contact with the subject is not a contraindication to the enrollment or ongoing participation of the subject in the study.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192426